Fibrosis Associated Protein Inhibitor (FAPI) Radiotracer-based Imaging to Identify Fibrotic Intestinal Crohn's Disease
Observational · No treatment assigned · 1 site · University of Edinburgh
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 90
- Any sex
Some of the main requirements, copied from the record:
- Crohn's disease with ileal involvement (including those with disease recurrence in the neo-terminal ileum) due to commence biologics.
There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- Start date: 2024-09-01.
- Main results expected around 2028-08-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Main thing being measured
- Fibrosis activity (36 months)
In the researchers’ words
Crohn's Disease (CD) is a chronic inflammatory condition that can affect any part of the intestine and currently has no cure. It affects 6.8 million people worldwide with UK healthcare costs in excess of £1 billion per year.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease |
| Lead sponsor | University of Edinburgh |
| Enrollment | 30 (estimated) |
| Start date | 2024-09-01 |
| Primary completion (est.) | 2028-08-01 |
| First posted | 2025-09-03 |
| Last updated | 2026-09-18 |
| Official title | FATE-CD: A Prospective Cohort Observational Study Investigating the Role of Fibrosis Activity in Crohn's Disease |
| ClinicalTrials.gov ID | NCT07152431 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * Crohn's disease with ileal involvement (including those with disease recurrence in the neo-terminal ileum) due to commence biologics. Exclusion Criteria: * Inability or unwilling to give informed consent. * History of claustrophobia or feeling of inability to tolerate supine position for the PET/MRI or PET/CT scans. * Impaired renal function with eGFR of <30 mL/min/1.73m2 * Women who are pregnant or breastfeeding. Pregnancy test will be performed in all women of childbearing age * Contrast allergy * Contraindication to MRI (e.g. metallic implant or severe claustrophobia) * Significant mental health conditions that will impair the ability to consent or affect their ability to take part in the study * Patients with colonic disease only with no ileal or small bowel involvement. * Contraindications (Glaucoma and/or ischaemic heart disease) or allergy (eg: anaphylaxis) to buscopan use.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| NHS Lothian | Edinburgh | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.